Job Purpose

To ensure that clinical studies are conducted at investigator sites in compliance with;

确保临床研究在调查地点的合规性;

·  the current approved protocol and any protocol amendment(s),

·  ICH GCP

·  GSK Written Standards

·  applicable local laws and regulatory requirement(s)

so that the rights, safety and well-being of human subjects is protected and that the reported study data is accurate, complete, and verifiable from source documents.

Key Responsibilities

• Fully accountable for All aspects of site management including ensuring completion and delivery of all local activities required to ensure high quality set up, execution and completion of studies to agreed timelines and budget.

• Communicate progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders e.g. CRA Manager/Lead as appropriate.

• Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities.

• Build effective long-term collaborative relationship, and to uphold the reputation of GSK.

Knowledge/Education/Experience

A. Educational Background

• Scientific Degree or Equivalent Experience

Any general science e.g. life science, medicine, clinical research, pharmacy etc

• This role requires a good understanding of scientific and medical information and inability to apply this understanding to the conduct of clinical research activities.

• Masters of Science or equivalent. Advanced degree preferred but not essential（专业、英文优秀本科生亦可）

B. Job-related experience

1~3-year experience of clinical study monitoring or equivalent experience in the clinical research field is an asset

Good English language written and verbal communication skills.

Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook)

Has some level of technical expertise